BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1981715 · Received February 8, 2011

    Report

    Report Number
    1628664-2011-00062
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 28, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    OMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION BEGAN WITH A REVIEW OF THE ARCHITECT I2000SR ANALYZER'S EVENT LOGS, WHICH DID NOT REVEAL ANY QUESTIONABLE DATA. AN ABBOTT FIELD SERVICE ENGINEER (FSE) WAS ON SITE FOR PLANNED/PREVENTIVE MAINTENANCE AND CONSIDERED THE INSTRUMENT TO BE IN PERFECT CONDITION; HOWEVER, THREE PARTS WERE REPLACED PROACTIVELY ON THE ANALYZER IN CONJUNCTION WITH THE SCHEDULED PLANNED/PREVENTIVE MAINTENANCE. NO FURTHER INSTRUMENT SERVICE CALLS HAVE BEEN INITIATED FOR THIS ANALYZER SINCE THE INITIAL CALL. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM CMV IGG ASSAY PACKAGE INSERT (LN: 6C15 (P/N 48-3349/R4, DECEMBER 2008)) AND THE ARCHITECT SYSTEM OPERATIONS MANUAL (P/N 201837-108, JANUARY 2010) BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. RESULTS OF THE CURRENT EVALUATION FAILED TO IDENTIFY A SINGLE DEFINITIVE CAUSE FOR THE CUSTOMER'S ISSUE. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PURPOSE OF THIS EVALUATION IS TO INVESTIGATE THE PERFORMANCE OF THE ARCHITECT CMV-IGG REAGENT KIT 6C15- 25 (LOT 92348LF00; EXPIRATION DATE 04 OCTOBER 2011). A RETAINED IN-HOUSE FILE SAMPLE OF THE ARCHITECT CMV-IGG REAGENT KIT PACK (LOT 92348LF00) WAS USED FOR TESTING. PERFORMANCE TESTING WAS CARRIED OUT USING AN IN-HOUSE SAMPLE OF ARCHITECT CMV IGG REAGENT (LIST 6C15-25, LOT 92348LF00). THE ARCHITECT CMV IGG TORCH NEGATIVE PANEL WAS USED TO ASSESS THE ACCEPTANCE CRITERIA (THE PANEL IS SERUM BASED AND THUS MIMICS PATIENT SAMPLES). AN ARCHITECT CMV IGG ASSAY CALIBRATION WAS SUCCESSFULLY GENERATED AND CONTROL MATERIAL PASSED, THUS VALIDATING THE CALIBRATION CURVE. TEN REPLICATES OF THE ARCHITECT CMV IGG TORCH NEGATIVE PANEL WERE ASSESSED ON AN ARCHITECT ANALYZER AGAINST THE SUSPECT REAGENT LOT. THE REAGENT LOT RETURNED RESULTS WHICH MET THE SPECIFIED LIMITS, DEMONSTRATING THAT THE REAGENT IS MEETING PERFORMANCE CLAIMS. THE DATA FORWARDED BY THE CUSTOMER WAS ALSO REVIEWED. THE CAUSE OF THE SPECIFIC DISCREPANT PATIENT RESULT SPECIFIED IN THE CUSTOMER COMPLAINT WAS NOT ABLE TO BE DETERMINED. IT SHOULD ALSO BE NOTED THAT THE CONTROL RESULTS REPORTED BY THE CUSTOMER MET PACKAGE INSERT SPECIFICATIONS INDICATING THAT THE REAGENT IS PERFORMING ACCEPTABLY. A REVIEW WAS ALSO CARRIED OUT OF THE TESTING PERFORMED BY THE QUALITY CONTROL LABORATORY PRIOR TO APPROVING THE ARCHITECT CMV IGG REAGENT 6C15-25, LOT 92348LF00 FOR SALE. ALL KIT RELEASE SPECIFICATIONS WERE MET, AND NO ISSUES WERE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY ISSUES RELATED TO THE CUSTOMER COMPLAINT THAT INDICATE THAT THERE IS A PRODUCT DEFICIENCY. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT CMV IGG REAGENT PACKAGE INSERT AND THE ARCHITECT I2000SR SYSTEM OPERATIONS MANUAL BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THE CURRENT INVESTIGATION, IT WAS DETERMINED THAT THE ARCHITECT CMV IGG REAGENT, LIST NUMBER 6C15-25, LOT NUMBER 92348LF00, IDENTIFIED IN THE COMPLAINT IS PERFORMING ACCEPTABLY. NO MALFUNCTION OF THE PRODUCT WAS DETERMINED AND NO ADDITIONAL ISSUES WERE IDENTIFIED DURING THE INVESTIGATION OF THIS COMPLAINT. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT A FALSE POSITIVE ARCHITECT CMV IGG ASSAY RESULT (22.8 AU/ML) WAS GENERATED ON A LIVER TRANSPLANT RECIPIENT. BEFORE THE SURGERY, A NEW SAMPLE WAS TAKEN AND TESTED AND GENERATED A NEGATIVE RESULT (1.3 AU/ML). THE INITIAL SAMPLE WAS RETESTED AND GENERATED A NEGATIVE RESULT (2.0 AU/ML). ALL PREVIOUS SAMPLES TAKEN FROM THIS PATIENT WERE THEN RETESTED AND ALL GENERATED NEGATIVE RESULTS. THE SAMPLES ALSO GENERATED NEGATIVE RESULTS WITH A NON- ABBOTT METHODOLOGY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER OMI ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH CMV IGG LN: 6C15-25| ARCH CMV IGG LN: 6C15-25 LOT:92348LF00| ARCH CMV IGG LN: 6C15-25